Privitera Mary Beth, Design M, Johnson Jeffrey
Medical Device Innovation and Entrepreneurship Program, Department of Biomedical Engineering, University of Cincinnati, Cincinnati, OH 45221, USA.
Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:5595-8. doi: 10.1109/IEMBS.2009.5333492.
The relationship between basic science research and product design/development are intertwined. This paper explores the definition of basic science and design as it relates to medical device development. It is intended to serve as a reference for both researchers and device developers to assist in trans-disciplinary collaborative efforts in improving patient care as each are of equal importance. The definition of a medical device is broad and varied. This paper is aimed towards those devices which interact with tissue and are rooted in the tenets of science. Both the scientific method and the design process are compared with similarities and opposites identified. The paper concludes identifying fundamental principles of medical device development and highlights the importance of both entities.
基础科学研究与产品设计/开发之间的关系相互交织。本文探讨了基础科学与设计的定义，及其与医疗器械开发的关联。旨在为研究人员和器械开发者提供参考，助力跨学科协作努力以改善患者护理，因为二者同等重要。医疗器械的定义广泛且多样。本文针对那些与组织相互作用且基于科学原理的器械。文中对科学方法和设计过程进行了比较，找出了它们的异同点。本文最后确定了医疗器械开发的基本原则，并强调了这两个方面的重要性。
